Harmonization of strategies for the validation of quantitative analytical procedures

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay et al. · Pharmaceutical Research · 2000 · 1.6K citations

Pharmacy, Biochemistry, Analytical Chemistry +11

Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Journal of Pharmaceutical Sciences · 1992 · 1.1K citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +14

Guidance for robustness/ruggedness tests in method validation

Yvan Vander Heyden, Arend Nijhuis, J. Smeyers–Verbeke et al. · Journal of Pharmaceutical and Biomedical Analysis · 2001 · 630 citations

Pharmacy, Pharmaceutical Analysis, Method Validation +9

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

John W. A. Findlay, W. Smith, J.W. Lee et al. · Journal of Pharmaceutical and Biomedical Analysis · 2000 · 582 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutics +11

Detection and quantification limits: origins and historical overview1Adapted from the Proceedings of the 1996 Joint Statistical Meetings (American Statistical Association, 1997). Original title: “Foundations and future of detection and quantification limits”. Contribution of the National Institute of Standards and Technology; not subject to copyright.1

Lloyd A. Currie · Analytica Chimica Acta · 1999 · 526 citations

Pharmacy, Biostatistics, Statistics +12